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Chr. Hansen secures initial approval of three HMOs in China

Chr. Hansen has secured initial approval for three human milk oligosaccharides (HMOs) in China, marking the first step towards aligning infant formula with breastmilk in the country, as part of its plan to introduce HMOs to the Chinese market. The Chinese Ministry of Agriculture and Rural Affairs (MARA) has recently approved three HMOs – 2’-FL, LNT and 3-FL – bringing Chr. Hansen's HMOs "one step closer to final approval for the Chinese market," said the company. HMOs are a major component of human milk, associated with multiple health benefits including "shaping a healthy infant gut microbiome, possibly supporting brain development and the maintenance of a well-balanced immune system, reducing the risk of bacterial imbalance and maturing and maintaining the integrity of the intestine". According to Chr. Hansen, 2’-FL is the most abundant HMO in breast milk and is known to support immune development and a balanced microbiome composition and is positively associated with neurodevelopment. LNT, another one of the most abundant HMOs in breast milk, represents the group of basic neutral HMOs that contribute to the benefits of breastfeeding for infants and a well-balanced gut microbiome by helping to limit the growth of undesired microorganisms. 3-FL is said to support the growth of beneficial bacteria in the gut and could support immunity by preventing harmful microbes from attaching to cells in the gut. Following these approvals, Chr. Hansen will then pursue the final nutrition fortifier approval process to secure market access in China. Jesper Sig Mathiasen, senior vice president of Chr. Hansen HMO, said: “This first Chinese regulatory approval of three of our HMOs is an important milestone in our quest to bring infant formula closer to breastmilk in China and our aim to market our HMOs to the world’s largest infant formula market. The approvals put us in a positive position to secure the final regulatory wins." The MARA approvals cover the technology to produce each of the three HMOs, enabling Chr. Hansen to apply for the final approval of all three HMOs with Chinese authorities. Additionally, Chr. Hansen will apply for Chinese approval of the remaining two HMOs in the clinically documented trademarked MyOli 5 HMO mix, which is already approved in the US and EU.

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